TOPCARE  ANTI-ITCH- diphenhydramine hydrochloride and zinc acetate cream 
Topco Associates LLC

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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TopCare®
Anti-Itch Cream

Drug Facts

Active ingredients Purpose
Diphenhydramine hydrochloride 2% Topical analgesic
Zinc acetate 0.1% Skin protectant

Uses

Warnings

For external use only

Do not use

  • on large areas of the body
  • with any other product containing diphenhydramine, even one taken by mouth

Ask a doctor before use

  • on chicken pox
  • on measles

When using this product avoid contact with eyes

Stop use and ask a doctor if

  • condition worsens or does not improve within 7 days
  • symptoms persist for more than 7 days or clear up and occur again within a few days

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Other information

Inactive ingredients

cetyl alcohol, glyceryl stearate, glyceryl stearate/PEG-100 stearate, methylparaben, propylene glycol, propylparaben and purified water

QUESTIONS?

1-888-423-0139

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton

TopCare®

EXTRA STRENGTH

Anti-Itch Cream 2%

DIPHENHYDRAMINE HYDROCHLORIDE 2%
AND ZINC ACETATE 0.1%

QUALITY
GUARANTEED

COMPARE TO
BENADRYL®
active ingredient*

NET WT 1 OZ (28.4 g)

PRINCIPAL DISPLAY PANEL - 28.4 g Tube Carton
TOPCARE   ANTI-ITCH
diphenhydramine hydrochloride and zinc acetate cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:36800-506
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Diphenhydramine Hydrochloride (UNII: TC2D6JAD40) (Diphenhydramine - UNII:8GTS82S83M) Diphenhydramine Hydrochloride 20 mg  in 1 g
Zinc Acetate (UNII: FM5526K07A) (Zinc Cation - UNII:13S1S8SF37) Zinc Cation 1 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
cetyl alcohol (UNII: 936JST6JCN)  
glyceryl monostearate (UNII: 230OU9XXE4)  
methylparaben (UNII: A2I8C7HI9T)  
propylene glycol (UNII: 6DC9Q167V3)  
propylparaben (UNII: Z8IX2SC1OH)  
water (UNII: 059QF0KO0R)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-506-02 1 in 1 CARTON
1 28.4 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part348 09/20/2005
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-506)

Revised: 1/2013
Document Id: 2cd8c13a-d8c7-4012-8e8d-38f429435e68
Set id: 7e824774-fec6-4ef9-8d0a-7907f3b7b886
Version: 1
Effective Time: 20130122
 
Topco Associates LLC